BlueCross BlueShield of Tennessee Medical Policy Manual

Epoetin Alfa

NDC CODE(S)

55513-0126 Epogen 2,000 U/ml solution for injection (Amgen)

 

55513-0267 Epogen 3,000 U/ml solution for injection (Amgen)

 

55513-0148 Epogen 4,000 U/ml solution for injection (Amgen)

 

55513-0144 & 55513-0283 Epogen 10,000 U/ml solution for injection (Amgen)

 

55513-0478 Epogen 20,000 U/ml solution for injection (Amgen)

 

59676-0302 Procrit 2,000 U/ml solution for injection (Janssen Biotech)

 

59676-0303 Procrit 3,000 U/ml solution for injection (Janssen Biotech)

 

59676-0304 Procrit 4,000 U/ml solution for injection (Janssen Biotech)

 

59676-0310 & 59676-0312 Procrit 10,000 U/ml solution for injection (Janssen Biotech)

 

59676-0320 Procrit 20,000 U/ml solution for injection (Janssen Biotech)

 

59676-0340 Procrit 40,000 U/ml solution for injection (Janssen Biotech)

DESCRIPTION

Erythropoietin is a glycoprotein produced in the kidneys responsible for the stimulation of red blood cell production.

Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology.  It is manufactured in the identical amino acid sequence of isolated natural erythropoietin.  Like the endogenous hormone, it stimulates increased production of red blood cells in individuals with functioning erythropoiesis and is referred to as an erythropoietin-stimulating agent or an ESA.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

Up to 150units/kg weekly

Most common starting dose

40,000 units weekly

 

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of epoetin alfa for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Epoetin alfa. Retrieved December 5, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, November). Epoetin alfa. Retrieved December 5, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Epoetin alfa. Retrieved December 5, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2013, December). Center for Drug Evaluation and Research. Label and Approval History. Reclast® (zoledronic acid) injection. Retrieved December 5, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103234s5323lbl.pdf.

ORIGINAL EFFECTIVE DATE:  1/14/2006

MOST RECENT REVIEW DATE:  2/27/2018

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Epoetin Alfa (Procrit®, Epogen®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #15

  1. Are the lab values obtained within 30 days of the date of administration (unless otherwise indicated) with initiation of therapy Hemoglobin (Hb) < 10 g/dL and/or Hematocrit (Hct) < 30% (unless otherwise specified)?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Are adequate iron stores demonstrated prior to therapy by serum ferritin ≥ 100 ng/mL (mcg/L) and transferrin saturation (TSAT) ≥ 20% (Intravenous iron supplementation may be taken into account when evaluating iron status) and causes of anemia other than the following covered diagnoses have been ruled out (e.g. hemolysis, bleeding, vitamin deficiency, etc.)?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of anemia secondary to myelodysplastic syndrome (MDS) with endogenous serum erythropoietin level of ≤ 500 mUnits/mL?

If yes, go to question #14

If no, go to question #5

  1. Does the individual have a diagnosis of anemia secondary to Myeloproliferative Neoplasms (MPN) (Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis) with endogenous serum erythropoietin level of ≤500 mUnits/mL?

If yes, go to question #14

If no, go to question #6

  1. Does the individual have a diagnosis of anemia secondary to Hepatitis C treatment with individual receiving interferon AND ribavirin?

If yes, go to question #14

If no, go to question #7

  1. Does the individual have a diagnosis of anemia secondary to rheumatoid arthritis?

If yes, go to question #14

If no, go to question #8

  1. Does the individual have a diagnosis of anemia secondary to chemotherapy treatment with ALL of the following?

If yes, go to question #14

If no, go to question #9

  1. Does the individual have a diagnosis of anemia secondary to chronic kidney disease (dialysis and non-dialysis patients)?

If yes, go to question #14

If no, go to question #10

  1. Does the individual have a diagnosis of anemia secondary to zidovudine treated, HIV-infected patients?

If yes, go to question #14

If no, go to question #11

  1. Does the individual have need of reduction of allogeneic blood transfusions in elective, non-cardiac, non-vascular surgery if ALL of the following?

If yes, go to question #14

If no, go to question #12

  1. Does the individual have a diagnosis of anemia secondary to multiple myeloma?

If yes, go to question #14

If no, go to question #13

  1. Does the individual have a diagnosis of anemia of prematurity when used in combination with iron supplementation?

If yes, go to question #14

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for ANY ONE of the following with dosage of up to 150units/kg weekly for an authorization period of 90 days?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the request show ALL of the following?

If yes, go to question #16

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the diagnosis of ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.